HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use DEPO-PROVERA CI safely and effectively. See full prescribing information for DEPO-PROVERA CI.
DEPO-PROVERA CI (medroxyprogesterone acetate) injectable suspension, for intramuscular use
Initial U.S. Approval: 1959 WARNING: LOSS OF BONE MINERAL DENSITYSee full prescribing information for complete boxed warning.- Women who use Depo-Provera Contraceptive Injection (Depo-Provera CI) may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible. (5.1)
- It is unknown if use of Depo-Provera CI during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life. (5.1)
- Depo-Provera CI is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate. (1, 5.1)
RECENT MAJOR CHANGESIndications and Usage (1) | 12/2020 |
INDICATIONS AND USAGE- Depo-Provera CI is a progestin indicated for use by females of reproductive potential to prevent pregnancy. (1)
Limitations of Use: The use of Depo-Provera CI is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate. (1, 5.1) DOSAGE AND ADMINISTRATION- The recommended dose is 150 mg of Depo-Provera CI every 3 months (13 weeks) administered by deep, intramuscular (IM) injection in the gluteal or deltoid muscle. (2.1)
DOSAGE FORMS AND STRENGTHS- Vials containing sterile aqueous suspension: 150 mg per mL (3)
- Prefilled syringes: prefilled syringes are available packaged with 22-gauge × 1 1/2 inch Terumo® SurGuard™ Needles. (3)
CONTRAINDICATIONS- Known or suspected pregnancy or as a diagnostic test for pregnancy. (4)
- Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease. (4)
- Known or suspected malignancy of breast. (4)
- Known hypersensitivity to Depo-Provera CI (medroxyprogesterone acetate or any of its other ingredients). (4)
- Significant liver disease. (4)
- Undiagnosed vaginal bleeding. (4)
WARNINGS AND PRECAUTIONS- Thromboembolic Disorders: Discontinue Depo-Provera CI in patients who develop thrombosis. (5.2)
- Cancer Risks: Monitor women with a strong family history of breast cancer carefully. (5.3)
- Ectopic Pregnancy: Consider ectopic pregnancy if a woman using Depo-Provera CI becomes pregnant or complains of severe abdominal pain. (5.4)
- Anaphylaxis and Anaphylactoid Reactions: Provide emergency medical treatment. (5.5)
- Liver Function: Discontinue Depo-Provera CI if jaundice or disturbances of liver function develop. (5.7)
- Carbohydrate Metabolism: Monitor diabetic patients carefully. (5.12)
ADVERSE REACTIONSMost common adverse reactions (incidence >5%) are: menstrual irregularities (bleeding or spotting) 57% at 12 months, 32% at 24 months, abdominal pain/discomfort 11%, weight gain >10 lbs at 24 months 38%, dizziness 6%, headache 17%, nervousness 11%, decreased libido 6%. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONSDrugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of contraceptive drug products. Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with Depo-Provera CI. (7.1) USE IN SPECIFIC POPULATIONS- Nursing Mothers: Detectable amounts of drug have been identified in the milk of mothers receiving Depo-Provera CI. (8.3)
- Pediatric Patients: Depo-Provera CI is not indicated before menarche. (8.4)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 12/2020 |